|
|
|
| Establishment of biological reference interval of renal function test items based on indirect method |
| ZHANG Chunjiao1, HUANG Rong2, CAI Tingting3, GU Jin1 |
1. Lianyungang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Lianyungang 222000, China;
2. Panyu Maternal and Child Care Service Centre of Guangzhou, Guangzhou 511400, China;
3. The Affiliated Hospital of Hebei University, Baoding 071000, China |
|
|
|
|
Abstract Objective To establish the reference interval of creatinine, urea and uric acid based on dry chemical system in Jiangsu、Guangzhou and Hebei by indirect method. Methods Collect laboratory information system (LIS) data from Lianyungang TCM Hospital Affiliated to Nanjing University of Chinese Medicine, Panyu Maternal and Child Care Service Centre of Guangzhou, and The Affiliated Hospital of Hebei University from January 1, 2023 to June 3, 2023. The K-S test was used to test the normality of the data, the interquartile range method was used to eliminate outliers, the Mann Whitney U test was used to classify the sex and age groups, and the percentage method (P2.5-P97.5) was used to establish the reference interval of each group, and compared with the reference interval of the manual. Results plasma creatinine, urea and uric acid were significantly different between sexes. There is no statistical significance in creatinine between the male under 30 years old group and the 31-60 years old group, and the reference interval can be established in combination. There is statistical significance between the other age groups, and the reference interval needs to be established separately. The biological reference interval of creatinine is 41.59-159.00 umol/L for men over 60 years old, 41.00-138.80 umol/L for men under 60 years old, 35.20-114.27 umol/L for women over 60 years old and 34.20-99.64 umol/L for women over 30 years old under 60 years old. The reference interval of urea is 3.50-11.20 mmol/L for men over 60 years old, 3.10-9.90 mmol/L for men over 30 years old, 2.39-8.95 mmol/L for men under 30 years old, 3.20-10.20 mmol/L for women over 60 years old, and 3.20-10.20mmol/L for women over 30 years old under 60 years old. The reference interval of uric acid is 165.35-570.93 umol/L for men over 60 years old, and 189.13-586.38 umol/L for men over 30 years old under 60 years old. The relative deviation of creatinine in men at all ages, creatinine in women over 60 years old, urea in men over 60 years old and urea in women over 60 years old are greater than RCV, indicating that there is a statistical difference between the self built reference range and the current reference range, and the self built reference range is required. The relative deviation between the self built reference range and the current reference range of other projects is less than RCV, indicating that the difference is not statistically significant. Conclusion There are sex and age differences in creatinine, urea and uric acid . Some items are different from the current reference interval, so it is necessary to establish a reference interval. Indirect method is a feasible method to establish the biological reference range of test items.
|
|
Received: 31 October 2023
|
|
|
|
|
|
[1] CLINICAL AND LABORATORY STANDARDS INSTITUTE. Defining, establishing, and verifying reference intervals in the clinical laboratory[S]. USA: EP28-A3, CLSI, 2010.
[2] 杨燕贻, 胡芸, 武明阳, 等. 长沙健康妊娠妇女新凝血标志物水平变化及其参考区间的建立 (英文)[J]. 中南大学学报 (医学版), 2022, 47(04): 469-478.
[3] 于正麟, 王扣琼, 王蓓丽, 等. VITROS XT 3400生化分析系统测定8种新型复合干片项目的性能验证[J]. 临床检验杂志, 2023, 41(06): 401-406.
[4] 李姗姗, 倪莉, 徐晓杰, 等. 温州地区儿童甲状腺激素和性激素水平分析[J]. 温州医科大学学报, 2022, 52(12): 965-971.
[5] 中国合格评定国家认可委员会. CNAS-CL02: 2012医学实验室质量和能力认可准则[S]. 北京: 中国合格评定国家认可委员会, 2013.
[6] 俞俊彤. 基于GAMLSS模型建立0~18岁人群的肾功能相关实验室检测指标的连续性参考区间研究[D]. 沈阳: 中国医科大学, 2023.
[7] 夏瑜. 常州地区健康成人心肌酶谱干化学法参考区间调查[J]. 检验医学与临床, 2019, 16(13): 1816-1818.
[8] 李佐祥, 刘梅, 侯腾, 等. 贵州省非职业接触汞健康人群血和尿汞水平及其参考值范围[J]. 贵州医科大学学报, 2023, 48(08): 908-913.
[9] 王艺婷, 李雪文, 邢东洋, 等. 间接法建立长春地区成人肝功能四项生化指标参考区间[J]. 临床肝胆病杂志, 2021, 37(09): 2161-2166.
[10] 李伟, 赵瑞, 祁朝阳, 等. 基于实验室数据建立河南地区甲状腺激素参考区间[J]. 医药论坛杂志, 2023, 44(12): 17-23.
[11] 贾永娟, 刘杏立, 刘春冉, 等. 应用间接法建立北京地区健康成人HPLC法测定血清维生素B1与B2水平的参考区间[J]. 现代检验医学杂志, 2022, 37(06): 149-152+157.
[12] 李雪文, 王艺婷, 何冰, 等. 基于健康体检人群检验大数据建立血清尿素、肌酐参考区间[J]. 临床检验杂志, 2021, 39(10): 795-797.
[13] 武艳, 秘玉静, 闫会敏, 等. 血清肌酐现行和原用参考区间临床应用价值比较[J]. 中华检验医学杂志, 2021, 44(03): 217-221.
[14] JONES GRD, HAECKEL R, LOH TP, et al.Indirect methods for reference interval determination review and recommendations[J]. Clin Chem Lab Med, 2018, 57(1): 20-29.
[15] 范雪莲, 蔡志梁, 黄惠伦, 等. 广州市海珠区妊娠妇女血清肾功能3项的检测和参考区间建立[J]. 国际医药卫生导报, 2020, 26(14): 2094-2097.
[16] 袁瑞, 楚淑芳, 余文辉, 等. 基于大数据建立第三代促甲状腺激素生物参考区间及其与年龄和气候的相关性[J]. 中华临床医师杂志 (电子版), 2021, 15(07): 491-496.
[17] 柴佳彤, 孙泽宇, 许建成. 基于LIS数据库使用Hoffman法和Bhattacharya法建立长春地区老年人群微量元素的参考区间[J]. 国际老年医学杂志, 2023, 44(04): 412-418.
[18] 杨术生, 李琼, 王伟, 等. 间接法建立血清肌酐参考区间[J]. 检验医学, 2018, 33(10): 879-883.
[19] EVGINA S, ICHIHARA K, RUZHANSKAYA A, et al.Establishing reference intervals for major biochemical analytes for the Russian population: a research conducted as a part of the IFCC global study on reference values[J]. Clin Biochem, 2020, 81: 47-58.
[20] 殷明刚, 余建洪. 自贡地区血清肾功检验项目参考区间的建立及分析[J]. 四川医学, 2016, 37(03): 277-280.
[21] 彭健桥, 赵东, 梁伟达, 等. 应用LIS大数据建立佛山地区儿童血清睾酮和雌二醇参考区间[J]. 检验医学与临床, 2022, 19(24): 3356-3359+3363. |
|
|
|
2024, Vol. 21 
